Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States, 28742-28746 [2021-11160]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Proposed Rules]
[Pages 28742-28746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 433, 438, 447, and 456

[CMS-2482-P2]
RIN 0938-AT82


Medicaid Program; Establishing Minimum Standards in Medicaid 
State Drug Utilization Review (DUR) and Supporting Value-Based 
Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug 
Rebate and Third Party Liability (TPL) Requirements: Delay of Effective 
Date for Provision Relating to Manufacturer Reporting of Multiple Best 
Prices Connected to a Value Based Purchasing Arrangement; Delay of 
Inclusion of Territories in Definition of States and United States

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: This proposed rule proposes to delay for 6 months the January 
1, 2022 effective date for amendatory instruction 10.a., which 
addresses the reporting by manufacturers of multiple best prices 
connected to a value based purchasing arrangement, of the final rule 
entitled, ``Medicaid Program; Establishing Minimum Standards in 
Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based 
Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug 
Rebate and Third Party Liability (TPL) Requirements'', published in the 
December 31, 2020 Federal Register. This proposed rule also proposes to 
delay for 2 years the April 1, 2022 effective date of inclusion 
(inclusion date) for U.S. territories (American Samoa, Northern Mariana 
Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended 
regulatory definitions of ``States'' and ``United States'' for purposes 
of the Medicaid Drug Rebate Program (MDRP), adopted in the interim 
final rule with comment period entitled, ``Medicaid Program; Covered 
Outpatient Drug; Further Delay of Inclusion of Territories in 
Definitions of States and United States'', published in the November 
25, 2019 Federal Register to April 1, 2024. In the alternative, we are 
proposing to finalize an inclusion date that may be earlier than April 
1, 2024, but not before January 1, 2023, based on public comments 
received. We are requesting public comment on the proposed delays of 
applicable effective date and inclusion date discussed in greater 
detail below.

DATES: To be assured consideration, comments on the proposals must be 
received at one of the addresses provided below by June 28, 2021.

ADDRESSES: In commenting, please refer to file code CMS-2482-P2.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-2482-P2, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2482-P2, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Christine Hinds, (410) 786-4578; Wendy 
Tuttle, (410) 786-8690.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the applicable comment period are available for viewing by the 
public, including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the applicable comment period on the 
following website as soon as possible after they have been received: 
https://www.regulations.gov. Follow the search instructions on that 
website to view public comments. CMS will not post on Regulations.gov 
public comments that make threats to individuals or institutions or 
suggest that the individual will take actions to harm the individual. 
CMS continues to encourage individuals not to submit duplicative 
comments. We will post acceptable comments from multiple unique 
commenters even if the content is identical or nearly identical to 
other comments.

[[Page 28743]]

I. Background

A. Proposed Delays in Effective and Inclusion Dates of Certain 
Regulation Provisions

    CMS is proposing to delay the January 1, 2022 effective date for 
amendatory instruction 10.a. of the final rule entitled, ``Medicaid 
Program; Establishing Minimum Standards in Medicaid State Drug 
Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) 
for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third 
Party Liability (TPL) Requirements'' (85 FR 87000), for 6 months to 
July 1, 2022, and to delay the April 1, 2022, inclusion date in the 
amended regulatory definitions of ``States'' and ``United States'', 
adopted in the interim final rule with comment period entitled 
``Medicaid Program; Covered Outpatient Drugs; Further Delay of 
Inclusion of Territories in Definitions of States and United States'' 
(84 FR 64783), for 2 years until April 1, 2024, or in the alternative, 
to a date earlier than April 1, 2024, but not before January 1, 2023.

B. Proposed Delay of Effective Date of Amendatory Instruction 10.a.

    On December 31, 2020, we published a final rule in the Federal 
Register entitled ``Medicaid Program; Establishing Minimum Standards in 
Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based 
Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug 
Rebate and Third Party Liability (TPL) Requirements'' \1\ (85 FR 87000) 
(hereinafter referred to as the December 31, 2020 final rule). The 
December 31, 2020 final rule advanced CMS' efforts to support state 
flexibility to enter into innovative value-based purchasing (VBP) 
arrangements with drug manufacturers for new and innovative, and often 
costly therapies, such as gene therapies, and codified new approaches 
required by section 1004 of the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and 
Communities Act (SUPPORT Act) (Pub. L. 115-271, enacted October 24, 
2018) and the existing Medicaid DUR program to improve the clinical use 
of opioids and reduce the potential for abuse in Medicaid patients. In 
addition, it codified in regulation several changes made in recent 
legislation and clarified other provisions of regulations relating to 
the Medicaid Drug Rebate Program (MDRP).
---------------------------------------------------------------------------

    \1\ https://www.federalregister.gov/documents/2020/12/31/2020-28567/medicaid-program-establishing-minimum-standards-in-medicaid-state-drug-utilization-review-dur-and.
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    The regulations included in the December 31, 2020 final rule went 
into effect on March 1, 2021, except for certain amendatory 
instructions, including instruction 10.a., which is effective on 
January 1, 2022. We are proposing to delay the January 1, 2022 
effective date for amendatory instruction 10.a. of the December 31, 
2020 final rule on manufacturer reporting of multiple best prices 
connected to a VBP arrangement, to July 1, 2022, and are seeking public 
comment on the proposed delay as outlined in section I.A. of this 
proposed rule. As discussed in greater detail in section II. of this 
proposed rule, we believe a delay of 6 months is warranted to assure 
that stakeholders have the ability to implement the new VBP policy in a 
manner that assures that patient access and quality of care is 
protected. We seek public comments on this proposed delay in the 
effective date, including the impact of this delay on affected 
beneficiaries. The primary reason for the original delay, and the new 
proposed delay, is to provide more time for CMS, states, and 
manufacturers to make the complex system changes necessary to implement 
the new best price and VBP program, and assure patient access and 
quality of care, given the current need to devote resources to the 
public health emergency (PHE) relating to COVID-19 that has been in 
effect, and will likely remain in effect through 2021.

C. Proposed Delay of Inclusion Date in Amended Regulatory Definitions 
of ``States'' and ``United States''

    The Covered Outpatient Drug (COD) final rule, published in the 
February 1, 2016 Federal Register (81 FR 5170), amended the regulatory 
definitions of ``States'' and ``United States'' to include the U.S. 
territories (American Samoa, Northern Mariana Islands, Guam, Puerto 
Rico, and the Virgin Islands) for the purposes of the MDRP with a 
delayed inclusion date of April 1, 2017. We stated in the preamble to 
the final rule that U.S. territories may use existing waiver authority 
to elect not to participate in the MDRP consistent with the statutory 
waiver standards. Specifically, the Northern Mariana Islands and 
American Samoa may seek to opt out of participation under the broad 
waiver that has been granted to them in accordance with section 1902(j) 
of the Act. The territories of Puerto Rico, the Virgin Islands, and 
Guam may use waiver authority under section 1115 of the Act to waive 
section 1902(a)(54) of the Act, which requires state compliance with 
the applicable requirements of section 1927 of the Act (81 FR 5203 
through 5204).
    The change to the definition of ``States'' and ``United States'' 
under the COD final rule to include the territories would also impact 
the quarterly calculation of average manufacturer price (AMP) and best 
price by manufacturers. That is, the change requires manufacturers to 
include prices paid by entities in the U.S. territories in the same 
manner in which they include prices paid by entities located in one of 
the 50 states and District of Columbia (81 FR 5224) in AMP and best 
price. It requires manufacturers to include eligible sales and 
associated discounts, rebates, and other financial transactions that 
take place in the U.S. territories in their calculations of AMP and 
best price once the revised definitions of ``States'' and ``United 
States'' take effect, regardless of whether the U.S. territories seek 
to waive participation in the MDRP.
    Once the COD final rule became effective, CMS began discussions 
with the territories regarding their participation in the MDRP. Based 
on those discussions, it became evident that interested territories 
would not be ready to participate in the MDRP by April 1, 2017. 
Stakeholders also reiterated the concerns in the comments to the COD 
final rule (81 FR 5224) that drug manufacturers will likely need to 
increase drug prices paid by U.S. territory Medicaid programs once the 
territories are included in the definitions of ``States'' and ``United 
States'' in order to avoid setting a new, lower best price. That is 
because if prices for drugs in the territories are lower than those in 
the states, then those prices could become the Medicaid best price for 
that drug in the entire Medicaid program. The manufacturers may then 
increase their drug prices in the territories to avoid this outcome, 
and an increase in drug prices in the territories could result in an 
increase in territory Medicaid drug spending without the offsetting 
benefit of receiving Medicaid rebates. Furthermore, the increase in 
Medicaid drug spending could adversely impact the availability of drugs 
to patients in the territories because of their Medicaid funding cap.
    As a result of these initial and subsequent discussions on 
preparedness, the potential for increased Medicaid drug prices in 
certain territories, and later, due to additional impacts of natural 
disasters in several of the territories, CMS issued two interim final 
rules with comment period (IFC) to further delay the

[[Page 28744]]

inclusion date for the U.S. territories in the regulatory definitions 
of ``States'' and ``United States'' for purposes of the MDRP. The 
first, the ``Medicaid Program; Covered Outpatient Drug; Delay in Change 
in Definitions of States and United States'' IFC, was issued on 
November 15, 2016, amending the regulatory definitions of ``States'' 
and ``United States'' to include the U.S. territories beginning April 
1, 2020, rather than to April 1, 2017 (81 FR 80003). The second, the 
``Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion 
of Territories in Definitions of States and United States'' IFC, was 
published on November 25, 2019, and further delayed the inclusion date 
for the regulatory definitions of ``States'' and ``United States'' to 
include the U.S. territories beginning April 1, 2022, rather than April 
1, 2020 (84 FR 64783).
    For similar reasons, in addition to ensuring continued beneficiary 
access and quality of care protections, we are proposing to amend Sec.  
447.502 to delay the April 1, 2022 inclusion date for the amended 
regulatory definitions of ``States'' and ``United States'' to April 1, 
2024, and are seeking public comment on the proposed delay as outlined 
in section I.A. of this proposed rule. As discussed in greater detail 
in section II. of this proposed rule, we believe an additional delay of 
2 years may be warranted because it would allow the territories to 
focus their human and financial resources on ensuring the health and 
well-being of their beneficiaries during this PHE, rather than having 
to divert those resources to the development of systems required to 
participate in the MDRP, which can take several years to implement from 
start to finish, and seek public comments on this proposal. However, if 
we determine based on public comments received from interested parties 
that the territories that want to participate in MDRP can do so sooner 
than April 1, 2024, and those that do not want to participate are able 
to complete the necessary waiver process, then we are proposing in the 
alternative to finalize a date that is sooner than April 1, 2024, but 
not earlier than January 1, 2023.

II. Proposed Delay in Effective and Inclusion Dates of Certain 
Regulation Provisions Due to Ongoing Public Health Emergency (PHE)

    On April 21, 2021, the Secretary of Health and Human Services (the 
Secretary) renewed the PHE initially declared on January 31, 2020, to 
continue giving CMS programs (including Medicaid) flexibility to 
support beneficiaries during the COVID-19 pandemic. This PHE is 
expected to last through 2021. In response to the PHE, CMS put in place 
its own pandemic plan (https://www.cms.gov/files/document/covid-pandemic-plan.pdf) to address the needs of its stakeholders, as well as 
the beneficiaries of its various programs including Medicaid. As part 
of that plan, CMS provided that it may approve waivers, amendments, and 
flexibilities for U.S. states, including the District of Columbia, and 
U.S. territories to allow Medicaid and CHIP programs to adapt their 
operations as necessary to respond to the pandemic. The pandemic plan 
also provided that it may make adjustments to the agency's value-based 
payment initiatives to allow health providers, healthcare facilities, 
Medicare Advantage and Part D plans, and States to focus on providing 
needed care to beneficiaries. In addition to the flexibilities granted 
to states under the PHE, the President signed into law on March 11, 
2021 the American Rescue Plan Act of 2021 (ARP) (Pub. L. 117-2) to 
address the health care and economic needs of the country during the 
pandemic. This law is one of the most significant expansions of 
Medicaid since enactment of the Affordable Care Act of 2010, and 
includes several new mandatory benefit requirements on states that will 
take time to implement.
    We acknowledged in the December 31, 2020 final rule that the 
changes to the reporting of multiple best prices by manufacturers under 
the MDRP (a VBP policy) adopted under the amendatory instruction 10.a 
would require additional time to provide operational guidance and 
complex system changes to implement. Thus, we delayed the effective 
date of the VBP provision until January 1, 2022. States that opt to 
participate in VBP models offered by manufacturers under the multiple 
best price approach must ensure that beneficiaries have appropriate 
access to care under such arrangements by developing systems and 
methods to track beneficiaries and their outcomes, retrieving and 
evaluating the patient-specific outcomes data, and securing the 
cooperation of providers and beneficiaries to enter into some of the 
more complex outcome-based arrangements offered by the manufacturers. 
Thus, there will be requirements on states to develop significant 
capabilities to build an infrastructure that will be able to implement 
VBP.
    We also want to be sure that our own technology infrastructure will 
be ready to receive multiple VBP offers from manufacturers that will 
report them to CMS, and subsequently report them to states. We are 
currently developing a new Medicaid Drug Program (MDP) system. This MDP 
system will replace CMS' current legacy system with certain aspects of 
the system expected to be transitioned in the summer of 2021. However, 
because of other events that have transpired since the regulation was 
published in December 2020, we do not believe that certain aspects of 
the system necessary for states and manufacturers to operationalize the 
VBP multiple best price program will be transitioned at that time, 
making a January 1, 2022 infeasible. We believe that it is important to 
have a technically up-to-date system that is ready to support the data 
requirements necessary for states and manufacturers to operationalize 
the VBP multiple best price program. However, we may have a delay with 
operationalizing that part of the MDP system by July 2021, which may 
mean we will not have the necessary CMS components in place by later 
this year to implement the program by January 1, 2022, and believe July 
1, 2022, is a realistic target date.
    Furthermore, the demands on researching, producing, and 
distributing COVID-19 drug treatments and vaccines have likely diverted 
some manufacturer financial and human resources from developing and 
implementing system changes that would be required to enter multiple 
best price offers in the MDP system.
    We understand that there is interest among patient and consumer 
groups, states, and manufacturers in the new multiple best price 
policy, and we are committed to implementing the VBP multiple best 
price policy in a manner that assures that Medicaid beneficiaries have 
access to medications and therapies that are appropriately administered 
and monitored. However, we are concerned that there are several 
challenges the states, providers, and manufacturers are facing during 
the PHE. These include, in addition to those resulting from the passage 
of the ARP, those relating to implementing expanded eligibility and 
mandatory benefit requirements under Medicaid (as described below). In 
sum, states, providers and manufacturers, as well as CMS, will need 
additional time to operationalize the multiple best prices policy under 
amendatory instruction 10.a.
    Therefore, given the possible delay in the MDP system and the 
recent developments around the PHE and ARP, we believe more time is 
critical to permit CMS and our partners--states, providers, and 
manufacturers--to successfully implement the multiple best prices 
approach so that Medicaid

[[Page 28745]]

patients benefit from these programs to full extent possible. 
Specifically, CMS and all the parties involved with the multiple best 
prices policies will want to make sure Medicaid patients receive the 
drug therapies under the VBP approach that are prescribed for them in a 
timely manner; that the VBP program does not create unnecessary 
barriers or requirements on the patient to access the drug; that they 
receive appropriately scheduled doses of a therapy if the patient 
treatment under the VBP arrangement is based on multiple doses; and 
that patient outcomes are tracked so that optimal patient care is 
provided; and, the states can obtain any additional discounts due to 
them from manufacturers under the VBP arrangement. At this time, we 
believe it is in the best interest of the Medicaid program and Medicaid 
beneficiaries, in particular, that states prioritize the Medicaid 
eligibility and benefit requirements under the ARP (for example, 
expanded optional Medicaid coverage for postpartum women, expansion of 
COVID-19 testing and treatment services, and expansion of vaccine 
administration to limited benefit groups), resulting from enactment of 
the ARP to address beneficiary needs during the COVID-19 pandemic, and 
therefore, propose a delay to the effective date for amendatory 
instruction 10.a. (the multiple best price approach) by 6 months 
(effective July 1, 2022). By allowing more time to address the needs of 
Medicaid beneficiaries during the PHE, states, CMS, providers, and 
manufacturers will also have more time to put in place appropriate 
beneficiary protections as part of the multiple best price approach.
    Therefore, we propose to delay the amendment associated with 
multiple best price requirements for 6 months, which if finalized, 
would make amendatory instruction 10.a effective beginning July 1, 
2022. We also expect to issue additional guidance before that time on 
operational and policy aspects of the new VBP program, including 
specifications relating to beneficiary protections.
    For the same reasons discussed above, we believe that in light of 
the pandemic and the resource demands stemming from the PHE (including 
those established under the ARP) on the Medicaid program and its 
beneficiaries, it is imperative that the territories prioritize the 
Medicaid eligibility and mandatory benefit requirements brought about 
by the ARP to address beneficiary needs during the COVID-19. Therefore, 
we believe that a further delay in the inclusion date of the U.S. 
territories in the regulatory definitions of ``States'' and ``United 
States'' is warranted and are proposing that they be included in those 
definitions beginning April 1, 2024. In the alternative, we are 
proposing to finalize an inclusion date that may be earlier than April 
1, 2024, but not before January 1, 2023, based on public comments 
received.
    By delaying the inclusion date to April 1, 2024, or in the 
alternative, a date earlier than April 1, 2024, but not before January 
1, 2023, we are allowing the territories additional time to develop 
needed systems and policy changes, in order to avoid unintended 
increases in drug costs and access concerns. The needed systems must be 
capable of collecting, reporting, validating, and tracking drug 
utilization on an ongoing basis. In addition, they require extensive 
advance planning and budgeting.
    The delay in inclusion date would also benefit those territories 
that choose not to participate in the MDRP, and therefore, would be 
required to use human and financial resources to complete the section 
1115 and section 1902(j) waiver applications that are required to waive 
out of MDRP participation should the current April 1, 2022 date remain 
in effect.
    Moreover, should the amended regulatory definitions of ``States'' 
and ``United States'' go into effect on April 1, 2022, all 
manufacturers' sales to the territories and prices paid would be 
included in the AMP and best price calculations at that time, 
regardless of whether the territory is participating in the MDRP. As 
discussed in the COD final rule (81 FR 5224), we heard from various 
stakeholders who expressed concerns that drug manufacturers would 
likely be prompted to increase drug prices, including prices paid by 
the U.S. territory Medicaid programs, once the territories are included 
in the definitions of ``States'' and ``United States.'' This is 
because, as currently drafted, section 1927 of the Act requires that 
eligible sales of drugs within the United States be included in the 
drug manufacturers calculation of Average Manufacturer Price (AMP) and 
best price. The inclusion of these prices in AMP and best price would 
result in the territories that receive a waiver realizing an increase 
in their Medicaid drug costs without the offsetting benefit of 
receiving Medicaid rebates. Furthermore, the increase in Medicaid costs 
could adversely affect territories because of their Medicaid funding 
cap. As noted above, that could result in an increase in drug prices in 
the territories, making drugs less affordable, and making it more 
difficult for the territories to address their own public health needs 
during the PHE. We believe this provides further rationale for delaying 
the inclusion date of territories in the regulatory definitions of 
``States'' and ``United States.'' It will ensure that during this PHE, 
which has the potential to extend into 2022, those territories that opt 
to waive participation from the MDRP will not face the additional 
financial burdens associated with increased Medicaid drug costs from 
drug manufacturers increasing drug prices to the territories.
    We are proposing a new inclusion date of April 1, 2024 for the 
amended regulatory definitions of ``States'' and ``United States'' to 
include the U.S. territories for purposes of the MDRP. In the 
alternative, we are proposing to finalize an inclusion date that may be 
earlier than April 1, 2024, but not before January 1, 2023, based on 
public comments received. Thus, we are specifically requesting comments 
from all interested parties on whether April 1, 2024, or an earlier 
inclusion date, but not earlier than January 1, 2023, would be more 
appropriate for the amended regulatory definitions. More specifically, 
we are requesting public comments that will assist us in understanding 
all relevant concerns related to establishing a new inclusion date, 
including whether territories are ready to participate in the MDRP, and 
whether CMS is able to execute appropriate and necessary waivers for 
territories that do not want to participate. In any case, manufacturers 
would be required to include their sales to the territories in their 
AMP and best price calculations based on the inclusion date finalized 
in a final rule, which we are proposing to be April 1, 2024, or 
possibly earlier, but no earlier than January 1, 2023 based on public 
comments.
    Therefore, we are requesting comment on our proposal to amend Sec.  
447.502 to delay the inclusion date for the the U.S. territories into 
the regulatory definitions of ``States'' and ``United States'' until 
April 1, 2024. We are also requesting comments on an alternative 
proposal, which is to finalize an inclusion date that may be earlier 
than April 1, 2024, but not before January 1, 2023, based on public 
comments received.

III. Response to Comments

    Because of the significant number of public comments we normally 
receive on Federal Register documents, we are not able to acknowledge 
or respond to them individually. We will consider all comments we 
receive by the date and time specified in the DATES section of this 
preamble for each applicable comment period, and, if and when we

[[Page 28746]]

proceed with a subsequent document, we will respond to the applicable 
comments in the preamble to that document, as appropriate.
    I, Elizabeth Richter, Acting Administrator of the Centers for 
Medicare & Medicaid Services, approved this document on May 18, 2021.

List of Subjects in 42 CFR Part 447

    Accounting, Administrative practice and procedure, Drugs, Grant 
programs--health, Health facilities, Health professions, Medicaid, 
Reporting and recordkeeping requirements, Rural areas.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 447--PAYMENT FOR SERVICES

0
1. The authority citation for part 447 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1396r-8.

0
2. Amend Sec.  447.502 by revising the definitions of ``States'' and 
``United States'' to read as follows:


Sec.  447.502  Definitions.

* * * * *
    States means the 50 States and the District of Columbia and, 
beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, 
the Virgin Islands of the United States, Guam, the Commonwealth of the 
Northern Mariana Islands, and American Samoa.
    United States means the 50 States and the District of Columbia and, 
beginning April 1, 2024, also includes the Commonwealth of Puerto Rico, 
the Virgin Islands of the United States, Guam, the Commonwealth of the 
Northern Mariana Islands, and American Samoa.
* * * * *

    Dated: May 21, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-11160 Filed 5-26-21; 4:15 pm]
BILLING CODE 4120-01-P